Status of GMOs and Products
Healthcare Applications
Under Clinical Trials
List of recombinant pharmaceutical/therapeutic products  recommended by RCGM for clinical trials to be conducted with the permission of Drug Controller General of India

S.No.

Product

  YEAR 2010
65
Chimeric monoclonal antibody (IgG1k) Abciximab
64
Palivizumab
63
Pandemic H1N1 and seasonal trivalent influenza VLP vaccines.
62
Human Granulocyte Colony Stimulating Factor (rh G-CSF)
61
Anti Rho (D) immunoglobulin
60
Human Insulin API (r-DNA origin)
59
Salmonella typhi strain expressing HPV18 L1 and HPV16 L1 VLPs for Oral Vaccine
58
Human Chorionic Gonadotropin (rHCG)
57
Human B-type Natriuretic peptide (rhBNP, VB17)
56
BioChaperone 1 (PDGF-BB+DMCTrp)

 

YEAR 2009

55
Human Interferon gamma-1b (IFNg)
54
Human Parathyroid Hormone (rHu PTH)
53
Combination Malaria Vaccine Composed of Recombinant PfMSP-119 and PfF2
52
Darbepoetin-alpha
51
Etanercept (TNFr-antibody fusion protein)
50
Teriparatide (rDNA origin) Injection (750 mcg/vial)
49
Human Follicle Stimulating Hormone (rFSH)
48
Human Platelet Derived Growth Factor-BB (PDGF-BB)
47
Human Interleukin 2 (r-hu-IL-2)

 

YEAR 2008

46
Bevacizumab
45
Trastuzumab
44
Human Parathyroid Hormone (rhPTH1-34)
43
THR-100 (recombinant staphylokinase)
42
Hepatitis B antigen in novel formulation
41

Tetravalent vaccines (DPT+HEP-B)

40

Pegylated Human IFN alpha- 2b [PegIFN alpha2b]

39

Urate Oxidase (VB 37)

38
Anti Rabies Human Monoclonal Antibody (SII RMab)

 

YEAR 2007

37

Human G-CSF

36

Somatropin

35

Pegylated recombinant methionyl human Granulocyte Colony Stimulating Factor (PEG-r-met hu G-CSF)

34

rh-Tissue Plasminogen Activator (tPA)

33

Polysialated Erythropoietin

32

Darbopoetin

31

Nesiritide

30

Insulin Glargine

29

IN-105 (Oral insulin)

YEAR 2006

28

Human tissue Plasminogen Activator (rh-TPA)

27

Pegylated r-h-erythropoietin

26

Pentavalent vaccine (Diphtheria, Tetanus, Pertusis, recombinant Hepatitis B and Haemophilus influenzae type B conjugate vaccine)

25

Rituximab (monoclonal antibody)

24

“BIOMAb EGFR” Humanized Anti-EGFR monoclonal antibody: Generic name Nimotuzumab injection) and Nimotuzumab-Bulk BIOMAb EGFR™-Bulk.

23

Monoclonal Tetanus Immunoglobulin

22

Human MAB RM1 IgGI.k

21

Human Granulocyte Colony Stimulating Factor (rh-G-CSF)

20

Hepatitis B antigen

19

Clinical evaluation of Relivax-DC for immunotherapy of prostate cancer

18

Tetravalent combination vaccine (DPT-r-Hepatitis B) and pantavalent combination vaccine (DPT-r-Hepatitis B + HIB)

17

Human Interferon alpha 2b (rh-IFNá2b)

16

Human Erythropoietin (rh-EPO)

YEAR 2005

15

Pegylated Granulocyte Colony Stimulating Factor (r-h-peg-G-CSF)

14

Lysostaphin gel

13

Granulocyte Colony Stimulating Factor (r-h-G-CSF)

12

streptokinase

11

Human Granulocyte-Macrophase Colony Stimulating Factor (r-hu-GM-CSF)

10

Pegylated Human Interferon Alfa 2b

9

Pentavalent combination vaccine consisting of Diphtheria, Tetanus, whole cell Pertussis, r-Hepatitis B & Hemophilus Influenzae type B (DTwPH-Hib)

8

TNK-t-PA

7

Human Follicle Stimulating Hormone (rh-FSH)

6

Interferon a2a

5

pegylated Interferon a2a

4

Interferon a2b

3

Pegylated Interferon a2b

2

Human interferon alpha 2b (rh-IFN  2b)

1

Erythropoietin